Use of Multiple Brain Imaging Modalities (PET and MRS) to Identify Metabolic Abnormalities in Major Depression

NCT01465165 | Terminated

• 1 other identifier: WIBR08-PJC
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Several lines of evidence support the existence of an underlying abnormality in brain energy metabolism may play a key role in the biology of mood disorders. The current study utilizes two distinct but complementary imaging techniques, fluorodeoxyglucose (FDG) positron emission tomography (PET) and multinuclear magnetic resonance spectroscopy (MRS), to better understand the nature of these metabolic abnormalities in major depressive disorder (MDD). The investigators hypothesize that individuals with depression will have increased metabolic activity as measured by PET in certain brain regions involved in mood regulation, but that this metabolic activity will be inefficient based on MRS findings. For this study, the investigators will study 10 medication-free, currently depressed participants with recurrent MDD, 10 depressed participants with recurrent MDD currently taking antidepressant medication, and up to 20 healthy control participants matched to depressed participants for age and gender. Depressed and healthy participants will each undergo one PET scan and one MRS scanning session.

Conditions

Major Depressive Disorder

Keywords

Depression; Positron emission tomography; Magnetic resonance spectroscopy; glucose metabolism; ATP; phosphocreatine

Outcome Measures

Primary Outcomes (1)

• high energy phosphate metabolites (Phosphocreatine (PCr)) as measured by magnetic resonance spectroscopy

  relative concentration of Pcr

  cross-sectional

Secondary Outcomes (3)

• regional cerebral glucose metabolism, as measured by Positron Emission Tomography (PET)

  cross-sectional

• N-Acetyl-Aspartate (NAA) metabolite intensity, as measured by proton Magnetic Resonance Spectroscopy (MRS)

  cross-sectional

• severity of depressive symptoms, as scored on the Montgomery-Asberg Depression Rating Scale (MADRS)

  cross-sectional

Study Arms (3)

Depressed, unmedicated

Participants with MDD who are not treated with any antidepressant medication

Depressed, on antidepressant

Participants with MDD, currently depressed but on a stable dose of an SSRI antidepressant

Healthy control

Healthy participant with no MDD or other psychiatric condition, matched by age and gender to MDD participants

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• Meet DSM-IV criteria for Major Depressive Disorder (MDD), Recurrent
• Montgomery-Asberg Depression Rating Scale (MADRS) score \> 18

You may not qualify if:

• Any coexisting psychiatric illness other than generalized anxiety disorder, panic disorder, or social/specific phobias
• Any history of substance dependence
• Substance abuse within the past 6 months
• Significant risk of suicide, as defined by score \>4 on item 10 of the MADRS or in the clinical judgment of the study physician
• Any significant medical or neurological condition which is likely to impact the central nervous system and/or affect the results of MRS or PET imaging
• For the subset of unmedicated MDD patients, any psychotropic medications within 4 weeks prior to scanning. For the subgroup of medicated patients, they may be taking a stable dose (i.e., same dose for at least 4 weeks at the time of scanning) of standard antidepressant medications, but may not be taking any other psychotropic medication.
• Inability to give informed consent
• Contraindication to MRI (e.g., pacemaker, ferromagnetic implants in the body)

Sponsors & Collaborators

• Paul Carlson: lead
• Western Institute for Biomedical Research: collaborator
• University of Utah: collaborator
• Molecular Imaging Program, Huntsman Cancer Institute: collaborator

Study Sites (1)

University of Utah Dept of Psychiatry

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Paul J Carlson, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 4, 2011
• Study Start: May 15, 2011
• Primary Completion: June 24, 2012
• Study Completion: June 24, 2012
• Last Updated: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)